Bio Pharma Dive

AUGUST 10, 2020

The biotech's value more than quadrupled after reporting pivotal data that, according to executives, "substantially exceeded" what's needed for approval.

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World of DTC Marketing

AUGUST 9, 2020

Pharma digital marketing has been lagging behind key trends for a long while. Let’s face it, pharma organizations are not made for speed while digital marketing is all about “now” Digital marketing is also about experimentation and learning from successes as well as failures. An internal team of consultants, dedicated to digital, can add a lot of value to a company.

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Marketing Branding Development 302

Camargo

AUGUST 13, 2020

Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo.

Development 144

Development Drugs 144

BioSpace

AUGUST 12, 2020

American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.

Gene 145

Gene Gene Therapy Clinical Trials Clinical Trials 145

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Clinical Supply

Bio Pharma Dive

AUGUST 10, 2020

Lawmakers questioned the timing of stock options granted to Kodak executives a day before the planned $765 million loan was announced. An SEC investigation is reportedly underway.

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World of DTC Marketing

AUGUST 13, 2020

IN BRIEF: Pharma companies have been posting jobs on LinkedIn almost every day. While most offices remain closed pharma is preparing for the launch of new products and has to have the infrastructure to ensure a successful launch. I keep in touch with all my clients via email newsletters and ask them to “stay in touch” It seems that this year, I’ve been seeing more people leave for other jobs within the industry or clients asking me to suggest people for open positions.

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Branding Pharma Companies Doctors Doctor 223

BioSpace

AUGUST 12, 2020

Researchers at the University of California, Riverside leveraged machine learning to screen more than 10 million commercially available small molecules for interactions with SARS-CoV-2 viral proteins, and found hundreds of drugs that might offer treatments against COVID-19.

Protein 141

Protein Drugs Research 141

Bio Pharma Dive

AUGUST 12, 2020

Viltepso, from Japanese drugmaker NS Pharma, is approved to treat the same subset of Duchenne patients as Sarepta's Vyondys 53.

Drugs 335

Drugs 335

Outsourcing Pharma

AUGUST 11, 2020

American Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.

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Trials Gene Clinical Development Development 145

pharmaphorum

AUGUST 12, 2020

Author and journalist John-Manuel Andriote has spent much of his career writing about the impact of HIV/AIDS – a job that became much more personal when he himself was diagnosed in 2005. He tells pharmaphorum about the importance of resilience in coping with a serious illness. John first began writing about HIV/AIDS as a journalist in 1986. “I had two friends of mine in their 20s die from AIDS while I was in journalism school in 1985 – a time when AIDS was always in the news and there was a lot

Doctors 128

Doctors Doctor 128

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

BioSpace

AUGUST 11, 2020

Although the world is eagerly awaiting news of an effective and safe vaccine against COVID-19, several companies are moving ahead testing therapeutic antibodies against the disease.

Antibody 140

Antibody Vaccination Vaccine 140

Bio Pharma Dive

AUGUST 11, 2020

The U.S. has already invested heavily in Moderna's vaccine, having previously committed $1 billion to fund clinical trials and manufacturing scale-up.

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Vaccination Vaccine Clinical Trials Clinical Trials 297

BioPharma Reporter

AUGUST 10, 2020

Moderna Therapeutics reveals it is selling its COVID-19 vaccine for up to $37 a dose, well above the amount charged by some of its rivals.

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Vaccination Vaccine Regulation Marketing 136

pharmaphorum

AUGUST 10, 2020

Why did I do that? A common question I often ask myself after opening the biscuit packet for the third time in an hour. Only ten minutes before I had a mental argument with myself, which I thought I had won, promising not to eat another one until tomorrow. The process that goes on inside our heads, affecting the good and bad choices we make regarding our health every day, is the focus of health psychology and the growing interest around behavioural change.

Genetics 124

Genetics Drug Delivery Research Pharma Companies 124

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

BioSpace

AUGUST 12, 2020

According to a study published in Nature Communications on August 11, enzymes that are used by bacteria to break down mucus in the gut can potentially be useful biomarkers for intestinal diseases.

Bacteria 137

Bacteria 137

Bio Pharma Dive

AUGUST 11, 2020

The shot, developed by the state-backed Gamaleya Research Institute, hasn't yet been tested in the large, placebo-controlled tests scientists emphasize are needed to prove a vaccine is protective.

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Vaccination Vaccine Scientist Development 274

Pharma Times

AUGUST 10, 2020

Pfizer becomes one of multiple external manufacturing organisations supporting scale-up of treatment

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Manufacturing 137

pharmaphorum

AUGUST 12, 2020

A new digital therapy is aiming to tackle depression during the COVID-19 pandemic, using a brain stimulation headset and therapy app that claims to have similar beneficial effects to drugs but with fewer side-effects. Flow is the first drug-free at-home treatment of its type to be approved in the EU and UK. While using the Flow headset, patients engaged with a therapy app program, which offers personalised behavioural therapy in areas proven to reduce symptoms of depression, including nutrition,

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Manufacturing Medicine Drugs Trials 117

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

BioSpace

AUGUST 13, 2020

Phase III clinical trials for Russia’s Sputnik V vaccine for COVID-19 began Wednesday, one day after the Russia Direct Investment Fund (RDIF) launched a new website to share the details of the vaccine with the public and scientists around the world.

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Vaccination Vaccine Trials Clinical Trials 137

Bio Pharma Dive

AUGUST 13, 2020

The manufacturing deal could help supply Latin America with Oxford's shot, which is one of the most advanced in clinical testing.

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Vaccination Vaccine Manufacturing 309

Pharma Times

AUGUST 13, 2020

If approved drug would offer a more flexible option for patients

Drugs 150

Drugs 150

pharmaphorum

AUGUST 14, 2020

After ditching its home-grown attempt at a coronavirus contact-tracing app for smartphones, the UK is ready to start pilot trials of a second version based on a platform developed by Apple and Google. The new NHS Test and Trace app is intended to be used as an add-on to the controversial national and local contact-tracing service, and was due to start initial trials yesterday on the Isle of Wight and among a group of NHS volunteers.

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Trials Development Research 116

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

BioSpace

AUGUST 13, 2020

Novavax entered into an agreement to provide the United Kingdom with 60 million doses of the vaccine should it be approved, as well as a late-stage efficacy study in that country.

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Vaccination Vaccine 133

Bio Pharma Dive

AUGUST 12, 2020

The drugmaker aims to double Black and Latinx representation in its executive ranks, among other commitments.

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XTalks

AUGUST 14, 2020

While the COVID-19 pandemic has disrupted the way consumers shop and food manufacturers operate, food safety remains a top priority for all stakeholders. The entire food supply chain is committed to meeting this expectation despite the fact that our new normal is changing from day-to-day. Many companies have successfully transitioned their meetings, events and even happy hours to virtual platforms to meet social distancing recommendations.

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Manufacturing Packaging Packaging Production 98

pharmaphorum

AUGUST 13, 2020

How the COVID-19 pandemic is forging pharmaceutical brands into better shape. Day by day it becomes clearer that some brands are coming through the pandemic in better shape than ever. These are the brands that have clearly demonstrated emotional intelligence, that have shown emotional empathy to their target audience. They understand the current, heightened emotional state of their customers and respond to it in ways that show they give a damn.

Branding 112

Branding Vaccination Vaccine Filler 112

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

BioSpace

AUGUST 11, 2020

Celleron Therapeutics signed a licensing agreement with Roche for the worldwide rights to cancer drug emactuzumab, a monoclonal antibody directed against colony-stimulating factor 1 (CSF-1R) expressed on macrophages.

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Drugs Licensing Licensing Antibody 129

Bio Pharma Dive

AUGUST 11, 2020

The unusual startup already has partial rights to multiple drugs developed by MyoKardia and affiliates of BridgeBio, and plans to acquire many more.

Drugs 257

Drugs Development 257

Pharma Marketing Network

AUGUST 14, 2020

2022 will usher in the demise of third-party cookies—that means pharma brands must change their approach to targeting and measurement. For decades, the third-party cookie has been a core component of any digital marketing strategy, allowing advertisers to deliver targeted ads and measure their effectiveness. However, with increased consumer privacy concerns and regulations, third-party cookies are set to expire by 2022.

Branding 98

Branding Marketing Regulation Development 98

pharmaphorum

AUGUST 14, 2020

Verona Pharma is to develop its lung drug ensifentrine for patients with COVID-19, joining the legions of drug companies repurposing their medicines to fight the pandemic. Based in the UK and US, Verona is due to start a phase 3 trial of ensifentrine in chronic obstructive pulmonary disease (COPD) later this year after encouraging results in phase 2.

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Trials Drugs Clinical Trials Clinical Trials 111

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Clinical Trials